UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027945 |
|---|---|
| Receipt number | R000031927 |
| Scientific Title | Clinical study to evaluate cardiac function parameters by acoustic cardiography for patients with acute decompensated heart failure |
| Date of disclosure of the study information | 2017/06/26 |
| Last modified on | 2019/03/26 11:54:15 |
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Basic information
Public title
Clinical study to evaluate cardiac function parameters by acoustic cardiography for patients with acute decompensated heart failure
Acronym
Clinical study to evaluate cardiac function parameters by acoustic cardiography for patients with acute decompensated heart failure
Scientific Title
Clinical study to evaluate cardiac function parameters by acoustic cardiography for patients with acute decompensated heart failure
Scientific Title:Acronym
Clinical study to evaluate cardiac function parameters by acoustic cardiography for patients with acute decompensated heart failure
Region
| Japan |
Condition
Condition
acute decompensated haert failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate cardiac function parameters by acoustic cardiography in patients with acute decompensated heart failure and their changes according to the levels of continuous positive airway pressure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in acoustic cardiography parameters
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Acoustic Cardiography, Continuous positive airway pressure
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients admitted due to acute decompensated heart failure
and
2) NYHA functional class 2 or more
and
3) Patients who gave written informed consent
Key exclusion criteria
1) Patients with implanted pacemaker and left ventricular assist device
2) Unstable angina, severe left ventricular arrhythmia, severe valve stenosis, hypertrophic cardiomyopathy, acute phase of myocardial infarction, severe respiratory disease, cardiogenic shock, severe hypotension, severe cerebrovascular disease, severe liver and renal dysfunction
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takatoshi Kasai |
Organization
Juntedo Hospital, Juntendo University School of Medicine
Division name
Cardiovascular Medicine
Zip code
Address
2-1-1 Hongo, Bunkyoku, Tokyo, Japan
TEL
03-3813-3111
tkasai@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Shitara |
Organization
Juntendo Hospital, Juntendo University School of Medicine
Division name
Cardiovascular Medicine
Zip code
Address
2-1-1 Hongo, Bunkyoku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
jshitara@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Asahi Kasaei Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 17 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 28 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 07 | Month | 25 | Day |
Date analysis concluded
Other
Other related information
Follow up sutdy was conducted for 1 year after discharge.
Management information
Registered date
| 2017 | Year | 06 | Month | 26 | Day |
Last modified on
| 2019 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031927
| Research Plan | |
|---|---|
| Registered date | File name |
| 2018/07/25 | 研究計画書 オーディコア.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
